HomeChinaSuzhou Medical Appliance Factory

Suzhou Medical Appliance Factory

China · 苏州 · www.hwato-med.com
✓ Record-verifiedregistrations found in 12 marketsEU SRN CN-MF-000015855Unified social credit code 913205051377025804

This company holds 45 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 11 overseas markets. EU UDI-DI records ≥1, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
45China registrations
Class I 16Class II 28Class III 1
as of 2026-09-04
EUEuropean UnionEUDAMED
≥1UDI-DI device records
Class IIa 1
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
6listed device types
Class I 4Class II 2Class III 0
plus 7 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
9registered device records
Class I 3Class IIa 6
BRBrazilANVISA
41registered devices
Class I 19Class II 22
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
5 including historic records
TWTaiwanTFDA
2valid device licences
Class I 1Class II 1
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Business type not stated 1
AUAustraliaTGA ARTG
8active ARTG entries
Class I 3IIa 3Class Is (sterile) 2
HKHong KongMDACS
2valid listings
Class II 2
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union22,198 raw hits, 99 excluded, 1 confirmed. Large result set — only the first 300 verified
United States7 registration records, 2 510(k), 0 PMA, 72 excluded
China45 certificates (Class III 1 / II 28 / I 16), as of 2026-09-04
United Kingdom9 confirmed, 25 excluded
Brazil41 confirmed, 33 excluded
Saudi Arabia0 confirmed, 12 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: Suzhou Medical Appliance Factory · CIXI ZHUOJIA ELECTRIC APPLIANCE FACTORY · SUZHOU HUANQIU ACUPUNCTURE MEDICAL APPLIANCE CO., LTD · SUZHOU HUANQIU ACUPUNCTURE MEDICAL APPLIANCE CO., LTD. · SUZHOU ACUPUNCTURE & MOXIBUSTION APPLIANCE FACTORY · SUZHOU MEDICAL APPLIANCE FACTORY

Regulatory identity

EU manufacturer SRN
CN-MF-000015855
EU authorised representative
Metrax GmbH
UK responsible person
E&E MEDICAL SUPPLIES LTD.
Unified social credit code
913205051377025804
Exhibition record
Rehab & Elderly Care Expo (Spring 2026, Shanghai) · Rehab & Elderly Care Expo (Spring 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
347
Annual revenue
over RMB 500M
Website
www.hwato-med.com
Product categories
中医版块手术室及急救

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
1980-12-21
Registered capital
CNY 66,000,000
Paid-in capital
CNY 66,000,000
Legal form
Limited liability company (wholly owned by a natural-person-controlled corporation)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-05-28
Recognitions
Micro and small enterpriseNational High-Tech EnterprisePrivate technology enterpriseSRDI SMEGazelle enterprise

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

12007 · K063568
12012 · K113463

FDA listed device types

Toothbrush, Powered 1Device, Pressure Applying 1Pack, Heat, Moist 1Floss, Dental 1Lamp, Infrared, Therapeutic Heating 1Needle, Acupuncture, Single Use 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20163022283可吸收性外科缝线Class III
CN苏械注准20262090854红外理疗灯Class II
CN苏械注准20252092217低频膝关节治疗仪Class II
CN苏械注准20252092173中频电疗仪Class II
EU16901452555135Sterile Acupuncture NeedlesClass IIa
UK43186NINELUCKClass IIa
UK58921NINELUCKClass I
UK32072NINELUCKClass I
USK113463POWER WHEELCHAIR2012-04-06
USK063568HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL2007-03-22
BR10150470470Agulha para Acupuntura (Cabo em Prata) WiltexClass II
BR10150470471Agulha para Acupuntura em Aço Inoxidável WiltexClass II
BR80102519392Agulhas de Acupuntura Estéreis Yuwell®Class II

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